1. Field of the Invention
The present invention is directed to pharmaceutical and/or dietary supplement compositions and methods of treating neuromuscular and other diseases, including but not limited to fibromyalgia, multiple sclerosis, muscular dystrophy, Alzheimer's, dementia, amyotrophic lateral sclerosis, depression, and/or rheumatoid arthritis. The present invention also encompasses pharmaceutical and/or dietary supplement compositions and methods of treating other physical ailments and disorders, including but not limited to pain, fatigue, sleeplessness, loss of fine motor control, speech loss, inflexibility, lyme disease, lyme disease co-infection, gastroparesis (GP), myopathy, chronic inflammation and/or incontinence. The method typically comprises administration to a subject in need thereof an anhydrous copper complex of formula C12H10ClCuN2O4. The invention also generally relates to pharmaceutical treatment regimes and methods of making the anhydrous copper complex of the present invention.
2. Discussion of the Background
A litany of human diseases and other ailments are characterized by neuromuscular degeneration and muscle weakness. The term “neuromuscular disease” refers to disorders that adversely affect muscle function and/or the control thereof by the central nervous system (CNS). In general, neuromuscular diseases encompass a wide range of physical ailments characterized by impaired muscle function. The following (non-limiting) list of conditions is generally recognized as neuromuscular diseases or conditions: multiple sclerosis, muscular dystrophy, rheumatoid arthritis, fibromyalgia, myopathy, inflammatory bowel disease (IBD), incontinence, inflexibility, impaired fine motor skills, and amyotrophic lateral sclerosis (“ALS” or Lou Gehrig's disease).
A stroke, formerly known as a cerebrovascular accident (CVA), often results in severe neurological impairment. Post-stroke, many individuals suffer one or more neurological impairments including, but not limited to: loss of fine motor control, paralysis, speech impairment/loss (aphasia and/or dysarthria), altered smell, taste, hearing, or vision, ptosis, ocular and facial muscle weakness, diminished reflexes, loss of balance, altered heart rate, apraxia, loss of memory, and/or confusion.
Numerous therapeutic methodologies are presently available for the treatment of neurological conditions such as the ones listed above. Efficacious treatments have proven elusive, however, and existing drugs with the most promise often exhibit the most undesirable side effects.
Two of the most prominent diseases associated with impaired neurological function are MD, MS and RA. These diseases and currently available treatments therefore, are discussed in greater detail herein below.
Muscular Dystrophy
The term Muscular Dystrophy (MD) actually refers to a group of diseases characterized by muscle weakness and/or impaired muscle function. The specific diseases include, but are not limited to Becker, Duchenne, and Emery-Dreifuss. Over 100 diseases, however, display symptoms similar to MD. All are characterized by reduced muscle function and muscle weakness.
No cure exists for MD and many of the related pathologies. Physical and occupational therapy may help those afflicted with MD manage life with the disease, but neither therapy ameliorates or reverses the disease's underlying causes or symptoms. Antisense oligonucleotides have shown promise as a treatment, but are costly and difficult to obtain for many MD patients. As a result, a significant need exists for a cost-effective, widely available treatment for MD (and related pathologies).
Multiple Sclerosis
Multiple Sclerosis (MS) is an autoimmune disease diagnosed in 350,000-500,000 people in the United States. The disease is characterized by multiple areas of inflammation and scarring of the myelin in the brain and spinal cord. Patients inflicted with the disease exhibit varying degrees of neurological impairment depending on the location and extent of the myelin scarring. Typical MS symptoms include fatigue, weakness, spasticity, balance problems, bladder and bowel problems, numbness, loss of vision, tremors, and depression. Available treatments of MS generally only alleviate symptoms or delay the progression of the disability. Recently developed treatments for MS (including stem cell implantation and gene therapy) appear to be only conservatory. Consequently, improved approaches for the treatment of MS are needed.
Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is another troublesome disorder associated with inflammation. It is signified by chronic inflammation in the membrane lining (the synovium) of the joints and/or other internal organs. These inflammatory cells can also damage bone and cartilage. For example, a joint inflicted with RA may lose its shape and alignment, which can result in the loss of range of motion. RA is characterized by pain, stiffness, warmth, redness and swelling in the joint, and other systemic symptoms like fever, fatigue, and anemia. RA currently affects roughly 1% of the entire U.S. population (approximately 2.2 million people). The pathology of RA is not fully understood, although it has been hypothesized to result from a cascade of aberrant immunological reactions.
In many cases, conventional treatments for RA have proven inefficient. For example, RA responds only partially to symptomatic medications such as corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs). These medications have been around since the 1950's, and possess a significant risk of contraindications. Moreover, the therapeutic effects of anti-rheumatic drugs (DMARDs) such as Methotrexate (MTX) are frequently inconsistent and only temporary. The latest class of “biologic” DMARDs (including ENBREL®, REMICADE®, HUMIRA®, and KINERET®) have shown promising treatment results, but significant concerns exist regarding their long term safety profile. For example, studies have shown an association between the use of both ENBREL® or REMICADE® and the development of lymphoma. Other reports have demonstrated that patients treated with either drug exacerbate their congestive heart failure and develop serious infection and sepsis, and aggravate symptoms of MS and other central nervous system problems. As with MS, a need exists for more effective treatments of RA.
Lyme Disease
Lyme disease is a bacterial infection (borrelia burgdorferi) spread by ticks. The number of reported cases of Lyme disease, and the number of geographical areas in which it is found, has been increasing. In addition to causing arthritis, lyme disease can also cause heart, brain, and nerve problems. Early symptoms include skin-rash, flu-like symptoms (.e.g. chills, fever, swollen lymph nodes, headaches, fatigue, muscle aches/pains, and joint pain). More advanced symptoms include nerve problems and arthritis. Currently, there is no available vaccine on the market in the US for lyme disease.
Lyme Disease Co-Infection
Often, ticks can become infected with multiple disease-causing microbes, resulting in co-infection. This may be a potential problem for humans, due to Borrelia burgdorferi, and other harmful pathogens carried and transmitted by some ticks. Possible co-infections with viruses such as lyme borreliosis, anaplasmosis, babesiosis, or encephalitis may occur. It is not known how co-infection may affect disease transmission and progression, but may help in diagnosing and treating lyme and other such diseases. Currently, there is no reliable and regular treatment for lyme disease co-infection.
Gastroparesis
Gastroparesis is a condition characterizes by the inability of the stomach to empty its contents, when there is no blockage (obstruction). The cause of gastroparesis is not known. There is some evidence that it may be caused by a disruption of nerve signals to the stomach. The condition is a complication of diabetes and of some surgeries. Risk factors associated with gastroparesis may include diabetes, gastrectomy (surgery to remove part of the stomach), systemic sclerosis, use of medication that blocks certain nerve signals (anticholinergic medication). Symptoms may include abdominal distention, hypoglycemia (in people with diabetes), nausea, premature abdominal fullness after meals, weight loss, and vomiting. If gastroparesis is caused by a condition that is reversible (e.g. pancreatitis), when the condition is resolved, the symptoms will subside. For some diabetics, better control of their blood sugar can also improve the symptoms. If there is no reversible cause, gastroparesis rarely resolves itself and the symptoms often grow more sever with time. When accompanied by motility disorders of the muscles of the small intestine, gastroparesis is particularly difficult to treat.